As the name implies, pharmaceutical gelatin is used in the production of pharmaceutical products. Some applications are direct, such as cod liver oil; others are indirect, such as hard capsules, where it serves as drug encapsulation material. Pharmaceutical gelatin is an important fine chemical raw material with a wide range of applications. In the past, however, apart from the technical specifications for “gelatin” listed in the pharmacopoeia, there was no formal standard for pharmaceutical gelatin.

In addition, the pharmacopoeia covered only a single gelatin variety, with incomplete technical items and specifications that could not fully reflect its actual range of applications. As the domestic hard capsule industry continued to grow, the Ministry of Health established the “Gelatin for Capsules” standard in 1988 to regulate the production of hard capsules and their main raw material, gelatin.

However, this standard applies only to the production of hard capsules. With no formal standard to follow for medical gelatin, both gelatin manufacturers and gelatin users have worked to different references: some based on edible gelatin standards, others on the “Capsule Gelatin” standard established by the Ministry of Health in 1988.

Therefore, there was an urgent need to establish a unified pharmaceutical gelatin standard to regulate the inconsistent production and usage requirements of the time.
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